ISO9000:2000

1
ISO90002000

• Topics Overview of ISO 9000
• 8 Principles of ISO90002000
• Benefits of ISO90002000
• Quality Management System
• Case studies

2
Overview

• History and evolution of ISO9000
• Benefits of ISO9000 and QMS
• 8 principles of ISO90002000
• Model for ISO90002000 with its clauses (5.0 to
  8.0)
• How to obtain an ISO9000
• Case studies

3
What is ISO90002000?

• ISO is the International Organization for
  Standardization. It is located in Switzerland and
  was established in 1947 to develop common
  international standards in many areas.
  Its members come from over 120 national standards
  bodies.
• The term ISO 9000 refers to a set of quality
  management standards. ISO 9000 currently includes
  three major quality standards
• ISO 90002000, ISO 90012000, and ISO 90042000. 
  
• Details for ISO90002000
• 9000 Fundamentals and Vocabulary (Concepts and
  Definitions)
• 9001 Quality Measurement System - Requirements
• 9004 Guidelines for Performance Improvements
  (TQM)
• 10012 Measurement Control
• 19011 Quality Management System/Environmental
  Management System (QMS/EMS) Auditing

4
Benefits of ISO90002000

• Internal
• Better management of core business processes
• Increased awareness of quality among staff
• Improved productivity and quality
• Improved internal communications
• Reduced costs of quality
• External
• Improved customer satisfaction
• Higher perceived quality by market place
• Quicker time to market new products
• Enhanced competitive edge
• Increased market share
• Particular Benefits to Non-Profit Organizations
• Transparency of processes
• Accountability to funding agencies and clients
• Third-party verification that organization has
  adopted sound business practices
• Increased credibility

5
ISO90002000 vs ISO900094

• ISO90002000 documents
• ISO90002000 QMS fundamentals and vocabulary
• ISO90012000 QMS requirements (only standard
  that can be audit)
• ISO90042000 QMS guidance for performance
  improvement
• ISO19011 Guidelines for QMS and EMS audit
• ISO900094
• ISO900194 - QMS for Design and development,
  production, installation and service
• ISO900294 - QMS for production, installation and
  service
• ISO900394 - QMS for inspection and testing
• ISO9004 91- Guidance to develop QMS
• ISO10011 - Guidelines for audit

6
Overview of ISO900094

• Quality standard First published in1987, revised
  in 1994
• Updated version (ISO 90011994, ISO90021994, and 
  ISO 90031994) republished in 2000
• Review of old standard in ISO900194 (20 clauses)

4.1 Management responsibility 4.2 Quality
system 4.3 Contract review 4.4 Design control 4.5
Document and data control 4.6 Purchasing 4.7
Control of customer-supplied product 4.8 Product
identification and traceability 4.9 Process
control 4.10 Inspection and test

• 4.11 Control of IMT
• 4.12 Inspection and test status
• 4.13 Control of NC product
• 4.14 Corrective and preventive action
• 4.15 Handing, storage, packaging, preservation
  and delivery
• 4.16 Control of quality records
• 4.17 Internal quality audit
• 4.18 Training
• 4.19 Servicing
• 4.20 Statistical techniques

7
Criticism of ISO900094

• Difficult to interpret
• Unsuitable for small business
• Biased towards MFG
• Lacking process-oriented management
• No good for CI
• Weak linkage with customer satisfaction
• Too many documentation
• Multiple management system in use is difficult
• Too many guideline standards

8
Objectives for the ISO90002000

• Enable harmonization/ integration of management
  system including ISO900, ISO14000, OHS18000
• Meet stakeholders requirements
• Enable implementation of continuous improvement
• Usable by organizations in all size and in all
  industry sectors
• Emphasis on effectiveness and efficiency
• Simple to use and easy to interpret
• Ensure adoption of process orientation
• Facilitate self-evaluation

9
Model for ISO90002000
Continuous Improvement of the QMS
5.0
Information flow
Customer (requirement)
Customer (satisfaction)
Management Responsibility
6.0
8.0
Information flow
Resource management
Measurement, analysis and improvement
7.0
output
input
Product Realisation
Product
10
8 Principles of ISO90002000

• The backbone of the new standard the 8
  principles
• 1. Customer focus
• 2. Leadership
• 3. Involvement of people
• 4. Process approach
• 5. System approach
• 6. Continuous improvement
• 7. Factual approach
• 8. Supplier relationship

11
Principles of ISO90002000

• Principle 1 Customer focus
• Organizations depend on their customers and
  therefore should understand current and future
  customer needs, should meet customer requirements
  and strive to exceed customer expectations
• Principle 2 Leadership
• Leaders establish unity of purpose and direction
  of the organization. They should crate and
  maintain the internal environment in which people
  can become fully involved in achieving the
  organizations objectives
• Principle 3 Involvement of people
• People at all levels are the essence of an
  organization and their full involvement enables
  their abilities to be used for the
  organsiationss benefit.
• Principle 4 Process approach
• A desired result is achieved more efficiently
  when activities and related resources and managed
  as a process

12
Principles of ISO90002000 (2)

• Principle 5 System approach
• Identifying, understanding and managing
  interrelated process as a system contributes to
  the organizations effectiveness and efficiency
  in achieving its objectives
• Principle 6 Continuous improvement
• CI of the organizations overall performance
  should be a permanent objective of the
  organization.
• Principle 7 Factual approach to decision making
• Effective decisions are based on the analysis of
  data and information
• Principle 8 Mutually beneficial Supplier
  relationship
• An organization and its suppliers are
  interdependent, and a mutually beneficial
  relationship enhances the ability of both to
  create value.

13
Principle 1 Customer focus

• Organizations depend on their customers and
  therefore should understand current and future
  customer needs, should meet customer requirements
  and strive to exceed customer expectations
• Applying the principle of customer-focused
  organization leads to the following actions
• understanding the whole range of customer needs
  and expectations for products, delivery, price,
  dependability, etc.
• ensuring a balanced approach among customers and
  other stakeholders (owners, people, suppliers,
  local communities and society at large) needs and
  expectations.
• communicating these needs and expectations
  throughout the organization,
• measuring customer satisfaction and acting on
  results, and
• managing customer relationships.

14
Principle 2 - Leadership

• Leaders establish unity of purpose and direction
  of the organization. They should crate and
  maintain the internal environment in which people
  can become fully involved in achieving the
  organizations objectives
• Applying the principle of leadership leads to the
  following actions
• being proactive and leading by example,
• understanding and responding to changes in the
  external environment,
• considering the needs of all stakeholders
  including customers, owners, people, suppliers,
  local communities and society at large,
• establishing a clear vision of the organizations
  future,
• establishing shared values and ethical role
  models at all levels of the organization,
• building trust and eliminating fear,
• providing people with the required resources and
  freedom to act with responsibility and
  accountability,
• inspiring, encouraging and recognizing people's
  contributions,
• promoting open and honest communication,
• educating, training and coaching people,
• setting challenging goals and targets, and
• implementing strategy to achieve these goals and
  targets.

15
Principle 3 - Involvement of People

• People at all levels are the essence of an
  organization and their full involvement enables
  their abilities to be used for the
  organsiationss benefit.
• Applying the principle of involvement of people
  leads to the following actions by the people
• accepting ownership and responsibility to solve
  problems,
• actively seeking opportunities to make
  improvements,
• actively seeking opportunities to enhance their
  competencies, knowledge and experience,
• freely sharing knowledge and experience in teams
  and groups,
• focusing on the creation of value for customers,
• being innovative and creative in furthering the
  organizations objectives,
• better representing the organization to
  customers, local communities and society at
  large,
• deriving satisfaction from their work, and
• be enthusiastic and proud to be part of the
  organization.

16
Principle 4 - Process Approach

• "A desired result is achieved more efficiently
  when related resources and activities are managed
  as a process.
• Applying the principle of process approach leads
  to the following actions
• defining the process to achieve the desired
  result,
• identifying and measuring the inputs and outputs
  of the process,
• identifying the interfaces of the process with
  the functions of the organization,
• evaluating possible risks, consequences and
  impacts of processes on customers, suppliers and
  other stakeholders of the process,
• establishing clear responsibility, authority, and
  accountability for managing the process,
• identifying the internal and external customers,
  suppliers and other stakeholders of the process,
  and
• when designing processes, consideration is given
  to process steps, activities, flows, control
  measures, training needs, equipment, methods,
  information, materials and other resources to
  achieve the desired result.

17
Principle 5 - System Approach to Management

• "Identifying, understanding and managing a system
  of interrelated processes for a given objective
  improves the organizations effectiveness and
  efficiency.
• Applying the principle of system approach to
  management leads to the following actions
• defining the system by identifying or developing
  the processes that affect a given objective,
• structuring the system to achieve the objective
  in the most efficient way,
• understanding the interdependencies among the
  processes of the system,
• continually improving the system through
  measurement and evaluation, and
• establishing resource constraints prior to action.

18
Principle 6 - Continual Improvement

• "Continual improvement should be a permanent
  objective of the organization."
• Applying the principle of continual improvement
  leads to the following actions
• making continual improvement of products,
  processes and systems an objective for every
  individual in the organization,
• applying the basic improvement concepts of
  incremental improvement and breakthrough
  improvement,
• using periodic assessments against established
  criteria of excellence to identify areas for
  potential improvement,
• continually improving the efficiency and
  effectiveness of all processes,
• promoting prevention based activities,
• providing every member of the organization with
  appropriate education and training, on the
  methods and tools of continual improvement such
  as
• - the Plan-Do-Check-Act cycle,
• - problem solving,
• - process re-engineering, and process innovation,
• establishing measures and goals to guide and
  track improvements, and
• recognizing improvements.

19
Use of ISO 9000 as Continuous improvement
20
Principle 7 - Factual approach to decision making

• "Effective decisions are based on the analysis
  of data and information."
• Applying the principle of factual approach to
  decision making leads to the following actions
• taking measurements and collecting data and
  information relevant to the objective,
• ensuring the data and information are
  sufficiently accurate, reliable and accessible,
• analyzing the data and information using valid
  methods,
• understanding the value of appropriate
  statistical techniques, and
• making decisions and taking action based on the
  results of logical analysis balance with
  experience and intuition.

21
Principle 8 - Mutually beneficial supplier
relationships

• "An organization and its suppliers are
  interdependent, and a mutually beneficial
  relationship enhances the ability of both to
  create value."
• Applying the principle of mutually beneficial
  supplier relationships leads to the following
  actions
• identifying and selecting key suppliers,
• establishing supplier relationships that balance
  short-term gains with long-term considerations
  for the organization and society at large,
• creating clear and open communications,
• initiating joint development and improvement of
  products and processes,
• jointly establishing a clear understanding of
  customers' needs,
• sharing information and future plans, and
• recognizing supplier improvements and
  achievements.

22
Requirement of ISO90002000

• 4 key areas in ISO90012000
• Management responsibility clause 5
• Resource Management clause 6
• Product realization clause 7
• Measurement, analysis and improvement clause 8
• Based on the 8 management principles
• As guideline for those whish to move beyond the
  minimum requirement of ISO90012000
• As guideline for achieving business excellence
  through continual improvement
• For achieving stakeholders benefits through
  sustained customer satisfaction
• Consistent with ISO90012000 for ease of use
• As a guideline for implementation of TQM approach

23
ISO90012000 QMS requirements (summary of
contents)

• 1. scope
• 2. normative reference
• 3. terms and definitions
• 4. QMS including general and document
  requirements
• 5. Management responsibilities including
  responsibilities and commitments from top
  management
• 6. Resource management including allocation of
  resources and competence of personnel
• 7. Product realization including, customer
  related, design, purchasing, product provision,
  validation of processes and products,
  identification and tractability and control of
  monitoring and measuring devices
• 8. Measurement, analysis and improvement include
  customer satisfaction, internal audit, monitor
  and measurement of processes and products,
  control of NC product, analysis of data and
  improvement (corrective and preventive action)

24
Definition of QMS

• System
• set of interrelated or interacting elements
• Management system
• system to establish policy and objectives and to
  obtain those objectives
• QMS
• Management system to direct and control an
  organization with regard to quality
• Benefit of a QMS
• identify and meet the needs and expectation of
  its customers and other interest parties
• achieve competitive advantage, and to do this in
  an effective and efficient manner
• achieve, maintain, and improve overall
  organization performance

25
Core of QMS in ISO9000

• 4.0 Quality management system
• Put structure in what you do
• 5.0 Management responsibility
• Put someone in charge
• 6.0 Resource management
• Provide the resources to achieve goals
• 7.0 Product realization
• Design and perform to requirements
• 8.0 Measurement, analysis and improvement
• Know where you are and get better

26
Clause 4 General requirements

• 4.1 General requirement
• The organization shall establish, document,
  implement and maintain a quality management
  system and continually improve its effectiveness.
  The quality management system documentation shall
  include documented statements of a quality policy
  and quality objectives, a quality manual and
  records.
• 4.2 Document requirement
• Documents required by the quality management
  system shall be controlled. Records are a special
  type of document and shall be established and
  maintained to provide evidence of conformity to
  requirements and of the effective operation of
  the quality management system. Records shall
  remain legible, readily identifiable and
  retrievable.
• 4.2.1 Requirements for document
• 4.2.2 Quality manual (http//www.tycoelectronics.c
  om/quality/)
• 4.2.3 Control of document
• 4.2.4 Controls of records

27
Document pyramid
Mission and Vision
One to two statements
Target
Why
2 to 10 pages
Policies
Who, where, When what
A manual with a few sections
Procedures to control
Work instructions
How
With many details table, charts, form
Guideline details steps to follow
Records
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Clause 5 Management Responsibilities

• 5.1 Management Commitment
• 5.2 Customer focus
• 5.3 Quality policy
• 5.4 Planning
• 5.4.1 Quality objectives
• 5.4.2 QMS planning
• 5.5 Responsibilities, authority and
  communications
• 5.5.1 responsibilities, authority
• 5.5.2 Management representative
• 5.5.3 Internal communications
• 5.6 Management review
• 5.6.1 Management review
• 5.6.2 MR input
• 5.6.3 MR output

29
Clause 6 Resource Management

• 6.1 Provision of resources
• The organization shall determine and provide the
  resources needed to implement and maintain the
  quality management system and continually improve
  its effectiveness, and to enhance customer
  satisfaction by meeting customer requirements.
  The necessary competence for personnel performing
  work affecting product quality shall be
  determined and training provided or other actions
  taken to satisfy these needs.
• Appropriate records of education, training,
  skills and experience shall be maintained.
• 6.2 Human resources
• 6.2.1 General
• 6.2.2 Competent, awareness and training
• 6.3 Infrastructure
• The infrastructure needed to achieve conformity
  to product requirements shall be determined and
  established. Infrastructure includes, buildings,
  workspace, associated utilities, process
  equipment (both hardware and software), and
  supporting services.
• 6.4 Work environment

30
Clause 7 Product Realization

• 7.1 Planning of product realization
• 7.2 Customer-related processes
• 7.2.1 Customer-related processes
• 7.2.2 Review of requirement
• 7.2.3 Customer communication
• 7.3 Design and development plan and control DD
  of product
• 7.3.1 D and D Planning
• 7.3.2 D D inputs
• 7.3.3 D D outputs
• 7.3.4 D D review
• 7.3.5 D D verification
• 7.3.6 D D validation
• 7.3.7 Control of DD changes

31
Clause 7 Product Realization (2)

• 7.4 Purchasing purchased product conforms to
  specified requirement
• 7.4.1 Purchasing process
• 7.4.2 Purchasing information
• 7.4.3 Verification of purchased product
• 7.5 Production and service provision plan and
  carry out production and service provision under
  controlled conditions.
• 7.5.1 Control of product and service provision
• 7.5.2 Validation of processes for production and
  service provision
• 7.5.3 Identification and traceability
• 7.5.4 Customer property
• 7.5.5 Preservation product
• 7.6 Control of monitoring and measuring devices

32
Clauses 8 Measurement, Analysis and improvement

• 8.1 General
• 8.2 Monitoring and measurement
• 8.2.1 Customer satisfaction
• 8.2.2 Internal audit
• 8.2.3 Monitoring and measurement of processes
• 8.2.4 Monitoring and measurement of product
• 8.3 Control of nonconforming product
• 8.4 Analysis of data
• 8.5 Improvement
• 8.5.1 Continual improvement
• 8.5.2 Corrective action
• 8.5.3 Preventive action

33
6 steps in obtaining a certificate

• Identify key processes
• Process series of connected actions each has
  a beginning ending point
• Process map shows relationship between
  processes throughout organization
• Design document system
• Four Levels of documentation
• Quality Policies Objectives
• Each process is documented into a Procedure
• Procedures refer to Work Instructions
• Quality Records - demonstrate conformance to
  system
• Implement and operate system
• Communicate throughout organization
• Departments perform work as described in
  procedures

• Internal audits
• Trained Internal Auditors
• Documented internal audit plan
• Audit results reviewed by management
• Make corrections improvements to quality system
• Registrar audit
• Documentation reviewed by auditor
• Registrar sends audit team
• On-site audit typically 2-3 days
• Auditors verify that system operates as outlined
  in procedure manual
• Recommend for registration
• Certificate issued
• Maintain registration
• Continue to operate quality system
• Surveillance audits (annual / semi-annual)
• 3-year cycle

34
Conclusions

• QMS
• Do more good than harms
• has a prevention mechanism
• It is a mechanism for continuous improvement to
  improve the following
• Quality policy
• Quality objective
• Audit result
• Analysis of data
• Corrective and preventive actions
• Management review

35
Summary (1) 8 principles

• The 8 principles in ISO90002000
• 1. Customer focus
• 2. Leadership
• 3. Involvement of people
• 4. Supplier relationship
• 5. Process approach
• 6. System approach
• 7. Factual approach
• 8. Continuous improvement

people related
system related
36
Summary (2) ISO90002000

• Fundamentals and vocabulary
• Establishes a starting point for understanding
  the standards and defines the fundamental terms
  and definitions used in the ISO 9000 family which
  you need to avoid misunderstandings in their use.
  
• Requirement
• This is the requirement standard you use to
  assess your ability to meet customer and
  applicable regulatory requirements and thereby
  address customer satisfaction.
• It is now the only standard in the ISO 9000
  family against which third-party certification
  can be carried.
• Guidance for performance improvement
• This guideline standard provides guidance for
  continual improvement of your quality management
  system to benefit all parties through sustained
  customer satisfaction
• Guidelines on QMS and EMS Audit
• Provides you with guidelines for verifying the
  system's ability to achieve defined quality
  objectives. You can use this standard internally
  or for auditing your suppliers.

• ISO 90002000
• ISO 90012000
• ISO 90042000
• ISO 19011

37
Summary (3) Benefits

• Advantages of ISO 90002000
• Can use in both manage and operate
• Able to apply in different field
• Easier to read and understand
• Reduce the time stand on building of document
• Compatible with other management systems
• Through the operation of QMS, it has a continuous
  improvement.
• To show the ability of company.
• Minimize the unnecessary product checking
• Increase the confidence of the buyer
• Make the product line to be more efficiency

38
Summary (4) core process model

• 5 core process of QMS
• 4.0 Quality management system
• Put structure in what you do
• 5.0 Management responsibility
• Put someone in charge
• 6.0 Resource management
• Provide the resources to achieve goals
• 7.0 Product realization
• Design and perform to requirements
• 8.0 Measurement, analysis and improvement
• Know where you are and get better

39
Case Study
40
Tai Wah Construction Ltd.

• The Hong Kong and Mainland China prominent wood
  products (door and flooring) company. By using
  their tremendous manpower, advanced processing
  equipment and rich experience in managing and
  controlling wood products production, they
  produce Mahogany, Ash, Red Oak, etc., solid wood
  doors and flooring characterized by elegant
  shape, splendid quality and authentic materials.

41
Certification of ISO90021994
42
Kai Shing Management Services Ltd.
 

• Established in 1978, Kai Shing Management
  Services Ltd. is now one of the largest and most
  reputable property management companies now in
  Hong Kong.
• They offer a full range of property management
  services, from management of single-ownership and
  multi-ownership properties, in the provision of
  security, cleaning, maintenance and property
  agency services.
• Kai Shing Management Services Ltd. was the first
  property management company in Hong Kong awarded
  the internationally recognized quality management
  certificate ISO 9002 by the HKQAA in 1996. In
  October 2001, it has been upgraded to meet the
  ISO 9001 (Version 2000) standard.

43
Kowloon Motor Bus (KMB)

• KMB was established in 1933 after obtaining a
  franchise to operate bus services in Kowloon and
  the New Territories. 'Pursuit of excellence' has
  been the corporate objective since the company's
  inception. KMB delivers this objective by
  providing safe, reliable, comfortable, friendly
  and value-for-money bus services.
• KMB was the 1st public bus company in H.K. to
  implement ISO Quality Systems throughout its
  entire organization. All aspects of KMBs bus
  service, including vehicle assembly, maintenance,
  network planning and operations, and support
  services, thus meet the highest international
  standards.
• KMB has 12 modernized depots, each equipped with
  the most advanced facilities to handle daily
  operations and servicing. The KMB Overhaul Centre
  at Tuen Mun is listed in the Guinness Book of
  Records for its scale of operations. Since 1973
  KMB has run its own apprentice training school to
  foster the professional development of its
  maintenance and repair staff